Cervical spine instability can cause permanent spinal cord damage. Trauma victims, as well as other patients with suspected cervical spine injury, should be immobilized during examination and diagnostic testing to reduce the risk of exacerbating a cervical spine injury. If cervical spine instability is confirmed on exam, the management of such injury depends on rapid realignment and rigid immobilization of the neck. Placing the patient in cervical traction may be necessary to reduce a fracture of the cervical spine. Once reduced, the fracture or other instability should be continuously immobilized to prevent further injury until a course of treatment can be completed. Often treatment will require a surgical procedure to fuse the unstable portion of the cervical spine.
A heightened awareness of, and a greater attention to, the maintenance of cervical immobilization has vastly improved patient care. Neck immobilization devices are currently available for each step of the management of cervical spine injuries, from initial immobilization to diagnostic tests, to the surgical fusion and the long-term immobilization often needed to promote effective healing. However, known devices are each limited in their application to only a portion of the diagnostic and treatment process. For example, the devices shown in U.S. Pat. Nos. 5,027,833; 5,016,620; 4,566,445; 4,529,106; 4,519,106 and 4,473,912 all relate to spinal boards which are applied at the scene of a traumatic injury, often in conjunction with a cervical collar or other head immobilization device, to facilitate the transport of the accident victim to a hospital. Some of these devices are designed to be radiolucent, but none provide an integrated system for placing the patient in rigid cervical immobilization once cervical instability is diagnosed. Additionally, none of these devices is designed to immobilize the patient during surgical procedures. U.S. Pat. No. 4,854,305 describes a transportable, radiolucent board that includes a traction device. However, this device does not offer the ability to place the patient in rigid cervical immobilization and is not designed for use during surgery.
When cervical instability is diagnosed, it should be reduced under radiographic guidance. Once the cervical fracture has been reduced, halo fixator devices are commonly used to rigidly immobilize the cervical spine until treatment is complete. In general, a halo device consists of a metal circlet (the halo) which surrounds the patient's head and is attached directly to the skull by a number of screws. The halo is fixedly attached to a rigid plastic vest on the patient's torso by metal bars, which run from the vest to a "head block" that is attached to the halo. The patient's head is thus immobilized relative to his or her torso, so that no cervical spine movement is possible. U.S. Pat. Nos. 5,156,588; 5,063,920; 5,010,881; 4,913,135; 4,735,196; 4,620,530; and 4,541,421 all describe various halo fixation devices. Such devices provide a transportable system for cervical immobilization, but their use is often impractical in the acute situation because halo vests have a size specification that should match the individual patient, and thus a proper vest may not be readily available. Furthermore, the vest should only be applied by a physician experienced in its use, and its placement limits health care workers' access to the patient's back, chest and abdomen. These issues are important in connection with the trauma patient, whose treatment must be expeditious and who also often has associated injuries that require medical access to the entire body. Additionally, if cervical immobilization is obtained by using a halo vest, it may be compromised during surgical procedures, because the vest must often be removed to allow greater surgical access to the patient's torso.
U.S. Pat. No. 5,063,920 describes a device that immobilizes a patient wearing a halo vest by attaching the posterior halo support rods to the patient's bed. The anterior support rods remain attached to the anterior section of the halo vest, but the posterior portion of the vest can be removed. However, this device does not allow for patient transport, is not radiolucent, does not provide unimpeded access to the patient's body, is not intended for use in surgical procedures and does not provide a means of cervical traction.
Numerous devices also exist which are designed to impart traction to the cervical spine. U.S. Pat. Nos. 5,195,947; 5,067,483; 4,890,605; 4,489,715; 4,539,979 each describe a type of traction device. Some of these are meant to be transportable and/or radiolucent, but none is designed as a part of an integrated system that allows traction, immobilization, transport and surgical access, as provided by the present invention.
The above-described devices may all be useful during certain stages of the acute management of a patient suspected of having a cervical spine injury, but the interruptions in immobilization resulting from limitations on their use can pose dangers to the patient. Especially in trauma patients, who may have multiple injuries, extensive diagnostic testing is often required. Such testing often requires patient transportation to several different locations, which can present difficulties if the patient requires cervical traction to maintain alignment of a cervical fracture. The traction device is usually attached to the patient's stretcher or some other traction bed, and removal of the traction is often necessary to move the patient onto the diagnostic testing machine.
Therefore, it is often necessary to repeatedly move patients among stretchers, dollies, testing tables, operating tables, and so forth, without adequate cervical support. During such moves, cervical immobilization is often lost or compromised, which can result in the loss of cervical alignment of the unstable spine and lead to further spinal cord damage and permanent neurologic injury.
The need for continuous cervical immobilization continues beyond the diagnostic testing phase because cervical instability often requires surgical treatment to fuse the spine. Halo fixation devices are often used during such surgery to maintain cervical immobilization. However, these devices restrict surgical access to the patient's body, complicating the harvest of bone needed for fusion and other procedures. In addition, in the trauma patient who often has significant life-threatening injuries in addition to cervical instability, a halo fixation system can be an impractical cervical immobilization device because it may prevent surgical access to the site of emergent injuries, which often are located on the abdomen, chest and back of the patient.
A general object of the present invention is to provide a new and improved transportable cervical immobilization device that obviates each of the problems in prior devices noted above.
Another object of the present invention is to provide a new and improved immobilization device of the type described that eliminates dangerous periods of cervical instability occasioned in moving the patient by providing an adjustable, transportable cervical immobilization device that can be used in each stage of the acute management of cervical instability, allowing rapid and secure transport from the emergency room, to the radiology department, to the operating room, and finally to the patient's recovery room.
Still another object of the present invention is to provide a new and improved device of the type described that provides rigid cervical immobilization during surgery, while providing unimpeded surgical access to the patient's torso and the option of using radiographic guidance intra-operatively.
Yet another object of the present invention is to provide a new and improved immobilization device that includes a means of attaching and/or removing cervical traction without having to remove the patient's cervical immobilization supports to do so.